ISO/FDIS 13504

• Abstract:

  This document specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. This document does not apply to devices used for indirect contact with the human body, including the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant. With regard to safety, this document gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.

• Status: Not Published
• ICS: 11.060.25 - Dental instruments
• Technical Committee: ISO/TC 106/SC 4 - Dental instruments
• Drafting Committee: ISO/TC 106/SC 4/WG 13 - Implant instruments
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 23-Jul-2026
• Completion Date: 23-Jul-2026

• Consolidates: FprEN ISO 13504 - Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/FDIS 13504:2026)
• Effective Date: 12-Feb-2026
• Consolidates: ISO/TS 20432:2022 - Guidelines for the determination of the long-term strength of geosynthetics for soil reinforcement
• Effective Date: 28-Oct-2023
• Revises: ISO 13504:2012 - Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
• Effective Date: 23-Sep-2023

Overview

ISO/FDIS 13504:2026 – Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment provides internationally recognized guidelines for the manufacture and control of dental instruments and accessories specifically designed for dental implant procedures. Published by the International Organization for Standardization (ISO), this standard applies to all instruments used directly in the placement of dental implants, whether single-use or reusable, and regardless of whether they are manually operated or connected to a power-driven system.

It addresses comprehensive safety requirements, including device classification, intended performance, performance attributes, material selection, manufacturing, sterilization, and the provision of information by manufacturers. The standard does not apply to the dental implants themselves, their directly connected components, or the systems used for indirect patient contact.

Key Topics

• Device Classification:
  Instruments and accessories are categorized based on:

  • Type of operation (manual or motor-driven)
  • Main tissue contact (hard tissue, soft tissue, or no direct tissue contact)
  • Reprocessing requirements (reusable or single-use)

• Intended Performance:
  Manufacturers must document and verify the functional and operational characteristics of dental implant instruments, ensuring safety and efficacy under intended use conditions.

• Performance Attributes:
  This includes assessment of physical, mechanical, and chemical properties, as well as resistance to wear, ease of cleaning, and suitability for repeated sterilization. Requirements also cover dimensional tolerances, contamination risk, biocompatibility, and usability.

• Material Selection:
  Materials must be selected in accordance with requirements and clarified in the standard’s normative annex, emphasizing long-term clinical safety and biological compatibility.

• Performance Evaluation:
  Pre-clinical and, if necessary, clinical evaluation of the instruments is required to demonstrate intended performance and safety, with reference to ISO 14971 for risk management and ISO 14155 for clinical investigations.

• Manufacturing and Documentation:
  Manufacturers are expected to maintain comprehensive technical documentation addressing design, classification, manufacturing processes, performance evaluations, and all information necessary to support safe use.

• Sterilization and Reprocessing:
  The standard establishes requirements for products supplied both sterile and non-sterile. Sterilization methods should comply with relevant ISO standards for health care product sterilization.

• Labelling and Instructions:
  Manufacturers must clearly label products with critical information including manufacturer details, lot or serial numbers, size or depth indicators, and usage instructions, using ISO-compliant symbols and terms where applicable.

Applications

ISO/FDIS 13504:2026 is crucial for a wide range of stakeholders in dentistry and medical device manufacturing, including:

• Dental Instrument Manufacturers:
  Ensures global harmonization of safety and performance requirements for dental implant procedure instruments.

• Regulatory Bodies:
  Provides a framework for compliance assessment and regulatory approval of dental implant instruments and accessories.

• Dental Professionals and Clinics:
  Enhances clinical safety, reliability, and traceability of tools used in dental implant placement, supporting high standards of patient care.

• Quality Managers:
  Offers a reference to implement or improve quality management systems for dental device production, with particular relevance to ISO 13485 alignment.

Related Standards

For comprehensive compliance and optimal quality, stakeholders should also consider the following related standards:

• ISO 13485 – Quality management systems for medical devices
• ISO 14971 – Application of risk management to medical devices
• ISO 14155 – Clinical investigation of medical devices for human subjects
• ISO 21850-1/2 – Materials for dental instruments
• ISO 11135, ISO 11137-1, ISO 17665 – Sterilization of health care products
• ISO 15223-1 – Symbols for labeling medical devices
• ISO 1942, ISO 16443 – Dentistry vocabularies

Implementing ISO/FDIS 13504:2026 supports safer, high-quality dental implant procedures and facilitates international market access for manufacturers of dental instruments and related accessories.

FINAL DRAFT
International
Standard
ISO/TC 106/SC 4
Dentistry — General requirements
Secretariat: DIN
for instruments and related
Voting begins on:
accessories used in dental implant
2026-07-23
placement and treatment
Voting terminates on:
2026-09-17
Médecine bucco-dentaire — Exigences générales relatives aux
instruments et aux accessoires connexes utilisés en implantologie
dentaire
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 106/SC 4
Dentistry — General requirements
Secretariat: DIN
for instruments and related
Voting begins on:
accessories used in dental implant
placement and treatment
Voting terminates on:
Médecine bucco-dentaire — Exigences générales relatives aux
instruments et aux accessoires connexes utilisés en implantologie
dentaire
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 2
4.1 Intended usage (application) . .2
4.2 Tissue contact .3
4.3 Reprocessing .3
5 Intended performance . 3
6 Performance attributes . 3
7 Material selection . 4
8 Performance evaluation . 4
8.1 General .4
8.2 Pre-clinical evaluation . .4
8.3 Clinical evaluation .4
9 Manufacturing . 4
9.1 General .4
9.2 Technical documentation .4
10 Reprocessing . 4
10.1 Products supplied sterile .4
10.2 Products provided non-sterile .5
10.3 Reprocessing information .5
11 Information to be supplied by the manufacturer . 5
11.1 General .5
11.2 Marking on instruments .5
11.3 Labelling on the package .5
11.4 Instructions for use .6
Annex A (normative) Acceptable materials for the manufacturing of instruments and
accessories used in dental implant placement and treatment . 7
Bibliography . 9

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106 Dentistry, Subcommittee SC 4, Dental
instruments, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 13504:2012), which has been technically
revised.
The main changes are as follows:
— normative references were updated to include all ISO documents referenced within this document;
— terms 3.1, 3.3.2, 3.3.3 and 3.3.4 were deleted;
— Clause 7 was revised to direct material selection to be in accordance with Annex A;
— reprocessing information was adapted in 10.3;
— Tables A.1, A.2 and A.3 were replaced with a reference to ISO 21850-1;
— Annex B was removed since this information is captured in ISO 21850-1.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
The use of dental implants is increasing throughout the world. Due to new and improved applications of
dental implants, the need for better instruments and related accessories for placing dental implants and the
further manipulation of connecting parts in the craniofacial area is also growing.
Materials present in instruments used in dental implant procedures have proven to be well tolerated.
Potential adverse reactions cannot be totally ruled out, but such reactions should be mitigated.
However, long-term clinical experience of the use of the materials referred to in this document has shown that
an acceptable level of biological response can be expected when they are used in appropriate applications
and when instruments are manufactured under appropriate design considerations and processes.

v
FINAL DRAFT International Standard ISO/FDIS 13504:2026(en)
Dentistry — General requirements for instruments and
related accessories used in dental implant placement and
treatment
1 Scope
This document specifies general requirements for the manufacture of instruments and related accessories
used in the placement of dental implants.
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or
connected to a power-driven system.
This document does not apply to devices used for indirect contact with the human body, including the power-
driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant.
With regard to safety, this document gives requirements for classification, intended performance,
performance attributes, material selection, performance evaluation, manufacture, sterilization and
information to be supplied by the manufacturer.
2 Normative references
The following documents are referred to in the text in such a way that some or all their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 2768-1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual
tolerance indications
ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
ISO 5832-3,
...

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CISO/DISFDIS 13504.2:2025(en)
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ISO/TC 106/SC 04/WG 13 4
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Secretariat: DIN
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Date: 2025-12-052026-07-08
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Dentistry — General requirements for instruments and related
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accessories used in dental implant placement and treatment
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Médecine bucco-dentaire — Exigences générales relatives aux instruments et aux accessoires connexes utilisés
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en implantologie dentaire
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St l D fi iti
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
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may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either
Formatted: Left: 1.5 cm, Right: 1.5 cm, Bottom: 1 cm,
ISO at the address below or ISO’s member body in the country of the requester.
Header distance from edge: 1.27 cm, Footer distance
from edge: 0.5 cm
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: [e-mail]
Formatted: French (Switzerland)
Website: www.iso.orgwww.iso.org
Formatted: English (United Kingdom)
Published in Switzerland
Formatted: English (United Kingdom)

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ii © ISO #### 2026 – All rights reserved
ii
ISO/DISFDIS 13504.2:2025:2026(en)
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Contents
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Foreword . v
Adjust space between Asian text and numbers
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification. 3
4.1 Intended usage (application) . 3
4.2 Tissue contact. 3
4.3 Reprocessing . 3
5 Intended performance . 3
6 Performance attributes . 3
7 Material selection . 4
8 Performance evaluation . 4
8.1 General. 4
8.2 Pre-clinical evaluation . 4
8.3 Clinical evaluation . 4
9 Manufacturing . 5
9.1 General. 5
9.2 Technical documentation . 5
10 Reprocessing . 5
10.1 Products supplied sterile . 5
10.2 Products provided non-sterile . 5
10.3 Reprocessing information . 5
11 Information to be supplied by the manufacturer . 5
11.1 General. 5
11.2 Marking on instruments . 5
11.3 Labelling on the package . 6
11.4 Instructions for use . 6
Annex A (normative) Acceptable materials for the manufacturing of instruments and
accessories used in dental implant placement and treatment . 8
Bibliography . 10

Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
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3 Terms and definitions . 2
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4 Classification. 3
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4.1 Intended usage (application) . 3 Tab stops: Not at 17.2 cm
4.2 Tissue contact. 3
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4.3 Reprocessing . 3
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5 Intended performance . 3
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iii
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6 Performance attributes . 4
7 Material selection . 4
8 Performance evaluation . 5
8.1 General. 5
8.2 Pre-clinical evaluation . 5
8.3 Clinical evaluation . 5
9 Manufacturing . 5
9.1 General. 5
9.2 Technical documentation . 5
10 Reprocessing . 5
10.1 Products supplied sterile . 5
10.2 Products provided non-sterile . 6
10.3 Reprocessing information . 6
11 Information to be supplied by the manufacturer . 6
11.1 General. 6
11.2 Marking on instruments . 6
11.3 Labelling on the package . 6
11.4 Instructions for use . 7
Annex A (normative) Materials found acceptable for instrument manufacture . 8
A.1 Materials . 8
A.2 Stainless steels . 8
A.3 Titanium and titanium alloys . 8
A.4 Ceramic materials . 8
A.5 Hard metals . 8
A.6 Coatings (only additive procedures) . 9
A.7 Surface treatment . 9
A.8 Polymers . 9
Bibliography . 11
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iv © ISO #### 2026 – All rights reserved
iv
ISO/DISFDIS 13504.2:2025:2026(en)
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Foreword
Formatted: HeaderCentered, Left
ISO (the International Organization for Standardization) is a worldwide federation of national standards
Formatted: Adjust space between Latin and Asian text,
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through Adjust space between Asian text and numbers
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Formatted: English (United Kingdom)
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents.www.iso.org/patents. ISO shall not be held responsible for identifying any or all such
patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
Formatted: English (United Kingdom)
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
Formatted: Adjust space between Latin and Asian text,
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Adjust space between Asian text and numbers
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.htmlwww.iso.org/iso/foreword.html.
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
This document was prepared by Technical Committee ISO/TC 106 Dentistry, Subcommittee SC 4, Dental
instruments, in collaboration with the European Committee for Standardization (CEN) Technical Committee Formatted: Default Paragraph Font
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
Formatted: Adjust space between Latin and Asian text,
(Vienna Agreement).
Adjust space between Asian text and numbers, Tab
stops: Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm +
This second edition cancels and replaces the first edition (ISO 13504:2012), which has been technically
3.5 cm + 4.2 cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
revised.
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The main changes are as follows:
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— — normative references were updated to include all ISO documents referenced within this document;
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— — terms 3.1,3.1, 3.3.2, 3.3.3 and 3.3.4 were deleted;
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— — Clause 7Clause 7 was revised to direct material selection to be in accordance with Annex A;Annex A;
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Adjust space between Asian text and numbers
— — reprocessing information was adapted in 10.3;10.3;
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— — Tables A.1, A.2Tables A.1, A.2 and A.3 were replaced with a reference to ISO 21850-1;
Formatted: Font: 10 pt
— — Annex B was removed since this information is captured in ISO 21850-1. Formatted: FooterCentered, Left, Space Before: 0 pt,
Tab stops: Not at 17.2 cm
Any feedback or questions on this document should be directed to the user’s national standards body. A
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complete listing of these bodies can be found at www.iso.org/members.htmlwww.iso.org/members.html.
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After: 0 pt, Tab stops: Not at 17.2 cm
v
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Introduction
The use of dental implants is increasing throughout the world. Due to new and improved applications of dental
implants, the need for better instruments and related accessories for placing dental implants and the further
manipulation of connecting parts in the craniofacial area is also growing.
Materials present in instruments used in dental implant procedures have proven to be well tolerated. Potential
adverse reactions cannot be totally ruled out, but such reactions should be mitigated.
However, long-term clinical experience of the use of the materials referred to in this document has shown that
an acceptable level of biological response can be expected when they are used in appropriate applications and
when instruments are manufactured under appropriate design considerations and processes.
Formatted: Font: 10 pt
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Formatted: Font: 11 pt
Formatted: FooterPageRomanNumber, Space After: 0
pt, Line spacing: single
vi © ISO #### 2026 – All rights reserved
vi
DRAFT International Standard ISO/DIS 13504.2:2025(en)

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Dentistry — General requirements for instruments and related
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accessories used in dental implant placement and treatment
Formatted
...
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...
1 Scope
Formatted
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This document specifies general requirements for the manufacture of instruments and related accessories
Formatted
...
used in the placement of dental implants.
Formatted
...
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or Formatted
...
connected to a power-driven system.
Formatted
...
Formatted
...
This document does not apply to devices used for indirect contact with the human body, including the power-
driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant.
Formatted
...
Formatted
...
With regard to safety, this document gives requirements for classification, intended performance,
Formatted
performance attributes, material selection, performance evaluation, manufacture, sterilization and .
information to be supplied by the manufacturer.
Formatted
...
Formatted
...
2 Normative references
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...
The following documents are referred to in the text in such a way that some or all their content constitutes
Formatted
...
requirements of this document. For dated references, only the edition cited applies. For undated references,
Formatted
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the latest edition of the referenced document (including any amendments) applies.
Formatted
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ISO 1043-1, Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics
Formatted
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ISO 1942, Dentistry — Vocabulary
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ISO 2768--1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual
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tolerance indications
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ISO 5832--2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
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ISO 5832--3, Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium
alloy
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ISO 11135, Sterilization of health care products — Ethylene oxide
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ISO 11137--1, Sterilization of health care products — Radiation — Part 1: Requirements for the development,
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validation and routine control of a sterilization process for medical devices
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ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice Formatted
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ISO 14971, Medical devices — Application of risk management to medical devices
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ISO 15223--1, Medical devices — Symbols to be used with information to be supplied by the manufacturer —
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Part 1: General requirements
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ISO 16443, Dentistry — Vocabulary for dental implants systems and related procedure .
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ISO 17664--1, Processing of health care products — Information to be provided by the medical device
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manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
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ISO 17664--2, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices -— Part 2: Non-critical medical devices
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